Home NDC 0781-2145 Ampicillin
Product NDC 0781-2145
11-digit product format 007812145
Labeler code 0781
Product ID 0781-2145_0202d39a-7586-4abd-9b9f-ac935aadccf2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Ampicillin
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application ANDA064082
Marketing category ANDA
Marketing start 1995-08-29
Substance AMPICILLIN TRIHYDRATE
Active strength 500 mg/1
Pharmacologic classes Penicillin-class Antibacterial [EPC], Penicillins [CS]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2020-06-10 20:45 UTC · source 2020-06-10 excluded product product 0781-2145 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0781-2145 0781-2145-01 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 0781-2145 0781-2145-05 I Inactivated by FDA excluded / ndc_excluded.zip 9bebd1f3094a…5416666fcb17…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A064082-001 AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 A064082-002 AMPICILLIN TRIHYDRATE AMPICILLIN/AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A064082-002 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB RS 1995-08-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL RS 1995-08-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL RS 1995-08-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL RS 1995-08-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL AB 1995-08-29 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL AB 1995-08-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL RS 1995-08-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A064082-001 AMPICILLIN TRIHYDRATE EQ 250MG BASE CAPSULE / ORAL 1995-08-29 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A064082-002 AMPICILLIN TRIHYDRATE EQ 500MG BASE CAPSULE / ORAL RS 1995-08-29 782e0a99824c…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Ampicillin
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AMPICILLIN TRIHYDRATE 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination HXQ6A1N7R6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 308212 Internal RxNorm lookup 313800 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0781-2145-01 Ampicillin 100 in 1 BOTTLE CAPSULE 100 18 0781-2145-05 Ampicillin 500 in 1 BOTTLE CAPSULE 500 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded AMPICILLIN TRIHYDRATE ACTIVE INGREDIENT HXQ6A1N7R6 AMPICILLIN CAPSULE [SANDOZ INC] 12 AMPICILLIN ACTIVE MOIETY 7C782967RD AMPICILLIN CAPSULE [SANDOZ INC] 12 AMMONIA INACTIVE INGREDIENT 5138Q19F1X AMPICILLIN CAPSULE [SANDOZ INC] 12 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMPICILLIN CAPSULE [SANDOZ INC] 12 GELATIN INACTIVE INGREDIENT 2G86QN327L AMPICILLIN CAPSULE [SANDOZ INC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMPICILLIN CAPSULE [SANDOZ INC] 12 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T AMPICILLIN CAPSULE [SANDOZ INC] 12 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMPICILLIN CAPSULE [SANDOZ INC] 12 SHELLAC INACTIVE INGREDIENT 46N107B71O AMPICILLIN CAPSULE [SANDOZ INC] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMPICILLIN CAPSULE [SANDOZ INC] 12 AMPICILLIN TRIHYDRATE ACTIVE INGREDIENT HXQ6A1N7R6 AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 AMPICILLIN ACTIVE MOIETY 7C782967RD AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 AMMONIA INACTIVE INGREDIENT 5138Q19F1X AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 BUTYL ALCOHOL INACTIVE INGREDIENT 8PJ61P6TS3 AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 GELATIN INACTIVE INGREDIENT 2G86QN327L AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 ISOPROPYL ALCOHOL INACTIVE INGREDIENT ND2M416302 AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 POTASSIUM HYDROXIDE INACTIVE INGREDIENT WZH3C48M4T AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 SHELLAC INACTIVE INGREDIENT 46N107B71O AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AMPICILLIN CAPSULE [PHYSICIANS TOTAL CARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-2145 AMPICILLIN CAPSULE [SANDOZ INC] 17 Current NDC, Legacy NDC, 2 package rows 20240514_0a66c5c3-63bf-46e3-835e-26b555ab6954.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-2145-01 00781214501 100 CAPSULE in 1 BOTTLE (0781-2145-01) 100 capsule 1995-08-29 0000-00-00 No No Current 0781-2145-05 00781214505 500 CAPSULE in 1 BOTTLE (0781-2145-05) 500 capsule 1995-08-29 0000-00-00 No No Current